Cleared Special

K081997 - PERFADEX WITH THAM

K081997 is an FDA 510(k) clearance for PERFADEX WITH THAM, manufactured by Vitrolife Sweden AB. The device is a Class 2 Gastroenterology & Urology device with product code MSB cleared through the Special 510(k) pathway after a 87-day FDA review.

K081997 · Vitrolife Sweden AB · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2008
Decision
87d
Days
Class 2
Risk

K081997 is an FDA 510(k) clearance for the PERFADEX WITH THAM. Classified as System And Accessories, Isolated Heart, Transport And Preservation (product code MSB), Class II - Special Controls.

Submitted by Vitrolife Sweden AB (Kungsbacka, SE). The FDA issued a Cleared decision on October 9, 2008 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5880 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K081997

510(k) Number K081997 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2008
Decision Date October 09, 2008
Days to Decision 87 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 131d · This submission: 87d
Pathway characteristics
Modification to existing cleared device.

MSB Device Classification - Class 2, Special Controls

Product Code MSB System And Accessories, Isolated Heart, Transport And Preservation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5880
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - MSB System And Accessories, Isolated Heart, Transport And Preservation

All 13
Devices cleared under the same product code (MSB) and FDA review panel - the closest regulatory comparables to K081997.
Sherpa Pak Cardiac Transport System
K143074 · Paragonix Technologies, Inc. · Nov 2014
SHERPA PAK CARDIAC TRANSPORT SYSTEM
K133432 · Paragonix Technologies, Inc. · Feb 2014
SHERPA PAK CARDIAC TRANSPORT SYSTEM
K123326 · Paragonix Technologies, Inc. · Feb 2013
CUSTODIOL
K032794 · Dr. Franz Kohler Chemie GmbH · Apr 2004
PERFADEX SOLUTION FOR LUNG PRESERVATION
K022730 · Vitrolife AB · Oct 2003
PERFADEX SOLUTION FOR ORGAN PRESERVATION
K000881 · Vitrolife Sweden AB · Mar 2001
K081997 · PERFADEX WITH THAM
Download PDF FDA Summary Vitrolife Sweden AB